Category: Drugs

Why Big Pharma is the Problem, not the Solution

In their never ending quest to extort rents from the rest of us, big pharma has a new tactic, it has established bogus “safety programs” that prohibit the sales of their drugs to generic manufacturers:

For decades, pharmaceutical companies have deployed an array of tactics aimed at preventing low-cost copies of their drugs from entering the marketplace.

But federal regulators contend the latest strategy — which relies on a creative interpretation of drug safety laws — is illegal.

The Federal Trade Commission recently weighed in on a legal case over the tactic involving the drug maker Actelion, and earlier this month a federal suit was filed in another case in Florida.

“We definitely see this as a significant threat to competition,” said Markus Meier, who oversees the commission’s health care competition team.

The new approach is almost elegant in its simplicity: brand-name drug makers are refusing to sell their products to generic companies, which need to analyze them so they can create the copycat versions. Traditionally, the generic drug makers purchased samples from wholesalers. But because of safety concerns, an increasing number of drugs are sold with restrictions on who can buy them, forcing the generic manufacturers to ask the brand-name companies for samples. When they do, the brand-name firms say no.

Brand-name companies say they are protecting themselves — and patients — in case the drugs are somehow used improperly. They say no law requires one company to do business with another.

Advocates for generic drugs say the practice could limit access to the low-cost drugs, which they say have saved more than a trillion dollars over the last decade. They say the companies that have most aggressively pursued the tactic tend to be those with drugs that are nearing the end of their patent life.

The problem is that Pharma can use its monopoly rents to continue to game the political system to f%$# the rest of us.

It needs to stop.

Judge Overturns Craven Obama Administration Morning After Pill Policy

A while back, in yet another attempt to appease right wing Neanderthals who will never support him, the Obama Administration overruled its experts at the FDA, and limited access to the morning after pill.

Well, a Federal Judge just called the decision, arbitrary, capricious and unreasonable:

A federal judge on Friday ordered that the most common morning-after pill be made available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. But his acidly worded decision raises a broader question about whether a cabinet secretary can decide on a drug’s availability for reasons other than its safety and effectiveness.

In his ruling, Judge Edward R. Korman of the Eastern District of New York accused the Obama administration of putting politics ahead of science. He concluded that the administration had not made its decisions based on scientific guidelines, and that its refusal to lift restrictions on access to the pill, Plan B One-Step, was “arbitrary, capricious and unreasonable.”

He said that when the Health and Human Services secretary, Kathleen Sebelius, countermanded a move by the Food and Drug Administration in 2011 to make the pill, which helps prevent pregnancy after sexual intercourse, universally available, “the secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent.”

This is a very well deserved smack down.

Of all the bits of cowardice to come out of the Obama administration over the past few years, this was arguably the most heinous.

India Rejects Evergreening Pharmaceuticals

The Indian Supreme Court has rejected a patent for a slightly modified drug, on the basis that it was not a significant change.

The drug companies do this all the time, in order to extend their patents on drugs nearly indefinitely:

People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while.

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

………

In Monday’s decision, India’s Supreme Court ruled that the patent that Novartis sought for Gleevec did not represent a true invention. The ruling is something of an anomaly. Passed under international pressure, India’s 2005 patent law for the first time allowed for patents on medicines, but only for drugs discovered after 1995. In 1993, Novartis patented a version of Gleevec that it later abandoned in development, but the Indian judges ruled that the early and later versions were not different enough for the later one to merit a separate patent.

Leena Menghaney, a patient advocate at Doctors Without Borders, said that the ruling was a reprieve from more expensive medicines, but only for a while.

“The great thing about this ruling is that we don’t have to worry about the drugs we’re currently using,” Ms. Menghaney said. “But the million-dollar question is what is going to happen for new drugs that have not yet come out.”

Others decried the ruling, saying it was further evidence that India does not respect the intellectual property rights of pharmaceutical companies. Last year, India granted what is known as a compulsory license to a generic drug manufacturer to begin making copies of Bayer’s cancer drug Nexavar, and revoked Pfizer’s patent for another cancer drug, Sutent. Both companies have appealed the decisions.

First, evergreening does not serve to create new products, it encourages minor, non-functional, changes to existing products to maintain a monopoly.

Second, compulsory licensing is specifically allowed for under all major international IP and trade regimes.

Unfortunately, when you look at intellectual protections (IP) as property it means that the holder of that monopoly has a God given right to extract unreasonable rents forever.

There is no place where our patent system is more broken than in the evergreening of pharmceuticals, and that is saying a lot.

Who Says that Irony is Dead

Yes, it’s ironic that one of the leading opponents of Marijuana decriminalization in New York State was was busted for possession, but true irony would involve him being beaten up by said cop”

Republican New York State Assemblyman Steve Katz (AD-99) was arrested Thursday morning for possession of marijuana after he was pulled over for speeding to Albany for a legislative session. The New York State Trooper who pulled over Katz smelled marijuana in the conservative Assemblyman’s car. Katz then surrendered a bag of weed to the Trooper.

Katz, who has strong Tea Party backing in the lower Hudson Valley, has opposed legalizing medical marijuana treatments for New Yorkers with conditions such as cancer and glaucoma while in the Assembly. The outspoken conservative with was first elected to the Assembly in 2010. He sits on the alcoholism and drug abuse committee, as well as its committees on higher education, mental health and economic development.

I do love the headline to this story though, “Katznip“.

Contemptible

Biotech firms are aggressively lobbying to ban the use of generic alternatives to their ruinously expensive drugs:

In statehouses around the country, some of the nation’s biggest biotechnology companies are lobbying intensively to limit generic competition to their blockbuster drugs, potentially cutting into the billions of dollars in savings on drug costs contemplated in the federal health care overhaul law.

The complex drugs, made in living cells instead of chemical factories, account for roughly one-quarter of the nation’s $320 billion in spending on drugs, according to IMS Health. And that percentage is growing. They include some of the world’s best-selling drugs, like the rheumatoid arthritis and psoriasis drugs Humira and Enbrel and the cancer treatments Herceptin, Avastin and Rituxan. The drugs now cost patients — or their insurers — tens or even hundreds of thousands of dollars a year.

Two companies, Amgen and Genentech, are proposing bills that would restrict the ability of pharmacists to substitute generic versions of biological drugs for brand name products.

Bills have been introduced in at least eight states since the new legislative sessions began this month. Others are pending.

Seriously. We need to move away from proprietary IP licensed drug development leveraging government research to another model.

The current one is not working.

They use monopoly rents to further expand their monopoly rents by capturing the political process, and we all pay, over, and over, and over, and over again.

XTC vs. PTSD, Why Not THC? EIEIO!

There are indications that MDMA (aka Ecstasy, E, X, and XTC) is showing promise in the treatment of post traumatic stress disorder, and limited clinical trials have been ordered:

Hundreds of Iraq and Afghanistan veterans with post-traumatic stress have recently contacted a husband-and-wife team who work in suburban South Carolina to seek help. Many are desperate, pleading for treatment and willing to travel to get it.

The soldiers have no interest in traditional talking cures or prescription drugs that have given them little relief. They are lining up to try an alternative: MDMA, better known as Ecstasy, a party drug that surfaced in the 1980s and ’90s that can induce pulses of euphoria and a radiating affection. Government regulators criminalized the drug in 1985, placing it on a list of prohibited substances that includes heroin and LSD. But in recent years, regulators have licensed a small number of labs to produce MDMA for research purposes.

(emphasis mine)

I’m an engineer, not a doctor, dammit,* so I really don’t have an informed opinion as to the therapeutic value of the drug, but when one considers the fact that THC (Tetrahydrocannabinol, the active ingredient in Marijuana) is denied this sort of research exemption, despite the fact that therapeutic effects have been fairly conclusively shown with Glaucoma and Multiple Sclerosis, as well as indications that it, much like MDMA, might be effective in the treatment of PTSD, it seems to me that something is seriously out of kilter with this process.

*I Love It when I get to go all Doctor McCoy!!!

I Think that I’ll Vacation in Uraguay

It looks like Uruguay will legalize marijuana and sell it through state stores:

The president of Uruguay, José Mujica, has announced plans to legalise the production and sale of marijuana under a state monopoly, triggering a lively controversy in Montevideo. The relevant bill will soon be tabled in parliament, where the governing centre-left coalition led by the Broad Front (FA) enjoys a majority but is divided on this issue.

Possessing and consuming marijuana was decriminalised in 2000. “There is no question of Uruguay producing and distributing drugs, but the state will control and regulate the market,” said interior minister Eduardo Bonomi.

“We have a progressive tradition,” said Bonomi who, with Mujica, belonged to the Tupamaros urban guerrillas in the 1970s. “At the beginning of the 20th century our country ended the prohibition of alcohol, prostitution and gambling.” Abortion is currently in the process ofbeing legalised. “Our approach to marijuana is equally pragmatic,” Bonomi said. “The negative effects of consuming marijuana are far less harmful than the outbreak of violence associated with the black market.”

Do they have ice cream sammiches in Uruguay?

China Mandates Compulsory Licensing of Pharmaceuticals

China has proposed compulsory licensing of drugs:

China has overhauled parts of its intellectual property laws to allow its drug makers to make cheap copies of medicines still under patent protection in an initiative likely to unnerve foreign pharmaceutical companies.

The Chinese move, outlined in documents posted on its patent law office website, comes within months of a similar move by India to effectively end the monopoly on an expensive cancer drug made by Bayer AG by issuing its first so-called “compulsory license”.

The action by China will ring alarm bells in Big Pharma, since the country is a vital growth market at a time when sales in Western countries are flagging.

The amended Chinese patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, or unusual circumstances, or in the interests of the public.

For “reasons of public health”, eligible drug makers can also ask to export these medicines to other countries, including members of the World Trade Organisation.

Compulsory licenses are available to nations to issue under WTO rules in certain cases where life-saving treatments are unaffordable.

“The revised version of Measures for the Compulsory Licensing for Patent Implementation came into effect from May 1, 2012,” China’s State Intellectual Property Office said in a faxed statement to Reuters.

The changes can be found on the website of China’s State Intellectual Property Office at http://link.reuters.com/tus68s

Here is the Google Translate link.

Number one on the compulsory licensing hit parade will apparently be the AIDS anti-viral tenofovir.

One significant part of this is that compulsory licensing is not covered by the ban on drug re-importation, because they weren’t exported from the US.

WTO rules would seem to indicate that, absent an extension of the law to cover compulsory licenses, that they would be legal in the US.

Then again, the phrase, “Drugs made in China,” gives me less confidence than, for example, French manners or British cooking,.

H/t Naked Capitalism.

Some Good News From the Texas Primary

Silvestres Reyes was defeated in the Tuesday primary by El Paso City Councelman Beta O’Rourke.

The district is overhwelmingly Democratic, so it means that O’Rourke is pretty much a shoe in for the general.

Why is this good news? Because Reyes was aggressively pro-drug war and pro drone, to the point of lobbying for drone stikes in Mexico, and O’Rourke supports Marijuana legalization.

It’s a big deal, and it shows that, as the NORML blog notes, the war on drugs is no longer the winning issue that it used to be.

Pat Robertson Wants Marijuana Decriminalized?

No, seriously, I am not joking:

Of the many roles Pat Robertson has assumed over his five-decade-long career as an evangelical leader — including presidential candidate and provocative voice of the right wing — his newest guise may perhaps surprise his followers the most: marijuana legalization advocate.

“I really believe we should treat marijuana the way we treat beverage alcohol,” Mr. Robertson said in an interview on Wednesday. “I’ve never used marijuana and I don’t intend to, but it’s just one of those things that I think: this war on drugs just hasn’t succeeded.”

Mr. Robertson’s remarks echoed statements he made last week on “The 700 Club” the signature program of his Christian Broadcasting Network, and other comments he made in 2010. While those earlier remarks were largely dismissed by his followers, Mr. Robertson has now apparently fully embraced the idea of legalizing marijuana, arguing that it is a way to bring down soaring rates of incarceration and reduce the social and financial costs.

“I believe in working with the hearts of people, and not locking them up,” he said.

Mr. Robertson’s remarks were hailed by pro-legalization groups, who called them a potentially important endorsement in their efforts to roll back marijuana penalties and prohibitions, which residents of Colorado and Washington will vote on this fall.

All this while the Obama administration doubles down on the war on drugs.

Rev. Robinson isn’t any smarter than the Obama administration, but he also hasn’t been captured by government bureaucracies , and he doesn’t feel the need to outflank his political opposition by running to the right, so he actually can consider what is optimal policy.

If Pat Roberson can get this right, anyone can.

The Drug War Sucks

We’ve kind of been rolling the trifecta with colds.

Sharon* has been on antibiotics for a cough and sinus for a few days, and after being blown off by our kid’s pediatrician’s replacement doc, so we went to an urgi-care clinic, and we got diagnoses for them, and me as well, since I had a nagging cough, and it had gotten bad enough that I wasn’t waiting until I saw my doctor at my regularly scheduled appointment with my doctor.

Charlie has a sinus infection, Natalie’s sinus infection migrated down to pharyngitis, and mine had migrated down to a full blown bronchitis.

In addition, Marilyn, my mother-in-law is at Sinai Hospital for what appears to be pneumonia.

So, what does this have to do with the drug war?

Well, in addition to antibiotics, both Charlie and I were prescribed decongestants, and both of these medications contained Pseudoephedrine, and so I could not buy both, because federal regulations say that it’s too much, and we might ………… cook meth.

The war on drugs is, to misappropriate the words of Nietzsche, like the bite of a dog into a stone, it is a stupidity.

*Love of my life, light of the cosmos, she who must be obeyed, my wife.

People I Do Not Want to Piss Off: Daily Show correspondent Aasif Mandvi


Blah, blah, blah!

He showed up to a press conference for Florida governor Rick Scott, and asked for a urine sample for a drug test:

Gov. Rick Scott and his drug testing policy became the unwitting target of Jon Stewart’s “Daily Show” on Wednesday as a reporter for the show broke into budget news conference and asked the governor to “pee into this cup.”

“You’ve benefitted from hundreds of thousands of taxpayer dollars over the years so would you be willing to pee into this cup to prove to Florida taxpayers that you’re not on drugs,” asked Comedy Central reporter, Aasif Mandvi. It was a reference to the governor’s drug-testing requirement imposed on all state employees and all welfare recipients.

Scott looked straight at him, didn’t miss a beat and said: “I’ve done it plenty of times.”

Mandvi then attempted to hand the sealed, official-looking collection cup to the governor. “We could all turn around, that’s fine,” he said.

At one point Mandvi persuaded other reporters to pass the cup to the front row but Scott ignored it. Mandvi asked again. “I hate to keep harping on this, would you pee in a cup?” Scott shot back: “You don’t get to run this.”

Last session, Scott persuaded the legislature to pass a law requiring all welfare recipients to pass a drug test but the measure was challenged by state Sen. Arthenia Joyner, D-Tampa, and the Florida chapter of the American Civil Liberties Union and put on hold by an Orlando court. Scott is appealing the ruling.

Remind me to never ever piss off anyone on The Daily Show, not even Steve the Intern, ever!

Meet the New Boss, Same as the Old Boss

The Marijuana Policy Project has just declared that Barack Obama is the worst President ever on medical Marijuana.

I think that this is not a deeply felt philosophy, but yet another case where a lack of ideology, or perhaps a contempt for ideology, that leads him to placate the most extreme of the dead enders, whether it be the drug war, or the Iraq war. (Where we were thrown out, we didn’t leave voluntarily)

What this means is that he doubles down more aggressively on bad policy than he would if he actually believed in it.

It’s kind a metaphor for his whole a political career.

H/t Disinformation.

Yummy Schadenfreude

A researcher at a pharmaceutical company was laid off shortly after another company acquired his employer, and shut down their research center.

Well, a few days ago, he was contacted by the blokes wot fired him, and asked to testify on their behalf in some patent litigation.

They offered a consulting fee and legal representation, but he declined, and contacted the attorneys for the other side.

His last sentence, “I explained that I do not want money but maybe they could re-evaluate how they are going to treat the R&D inventors in the future. You know, in case they need them again,” is a hoot.

This Joint Kills Fascists

Click for full size


This is your brain


This is your brain on drugs … Any Questions

About 5 years ago, a couple of young twins (about 14) achieved some notoriety as the singing group called “Prussian Blue.”

It was a white white supremacist group.

Well, these days, the girls have renounced racism, and they credit marijuana for their change of heart:

Lamb and Lynx Gaede, whose band Prussian Blue was popular back in 2005 among those inclined to like such things, ascribed their unsavory past to having been “home schooled country bumpkins” heavily influenced by their domineering white supremacist mother, reports Neurobonkers.

The twins back when they were little 13-year-old Nazis about six years ago
​Since then the twins, who turned 19 on June 30, have moved to Montana to attend high school, where in her first year Lynx was diagnosed with both cancer (which led to removal of a tumor) and cyclic vomiting syndrome (CVS). Lamb developed scoloiosis and back pain, “as well as lack of appetite and intense emotional stress.”

Both of the girls, who sort of became the white supremacist equivalent of the Olsen Twins, began using marijuana after Lynx had a bad reaction to the harsh pharmaceutical narcotics Oxycontin and morphine, which a doctor had prescribed to treat her pain.

“I have to say, marijuana saved my life,” Lynx said. “I would probably be dead if I didn’t have it.”

Lynx became one of the first five minors in Montana to get a medical marijuana card, and Lamb now has one, too. One can only wonder what will become of the girls now that Montana’s conservative Republican-controlled Legislature has all but repealed the state’s compassionate medical marijuana law, approved by 62 percent voters in 2004.

Apparently, the marijuana didn’t just ease the physical pain, but also quelled the psychological hatred that had been inculcated in the girls by their racist upbringing.

No, this is not The Onion.

When Liberal Policies Save Money

Philadelphia, PA effectively decriminalized possession of small quantities of marijuana and saved big bucks in the process:

Just over a year ago, the powers that be in Philadelphia effectively decriminalized possession of small amounts of marijuana by offering offenders the chance to enroll in a three-hour class that would expunge the offense from their records. Not only did this give Philadelphia police more time and energy to focus on more serious crimes, it has also saved the city a pretty sizable Ziploc bag of green stuff.

“We were spending thousands of dollars for when someone possessed $10 or $15 worth of weed,” District Attorney Seth Williams tells the Philadelphia Daily News. “It just didn’t make any sense.”

Under the program, being caught with up to 30 grams of marijuana is no longer a misdemeanor but a summary offense. By simply paying $200 to attend the three-hour class on the ills of drug use and abuse, the arrestee’s record is wiped clean of the offense.

Before this change, offenders faced up to $500 in fines and possible, though unlikely jail time. If the suspect fought the charges, this meant expenses for the city — prosecutors, judges, lab tests, public defenders, etc. By all but decriminalizing pot, Williams estimates that the city has saved $2 million in the last 12 months.

Additionally, police tell the News that there has been no noticeable impact on the quality of life in Philadelphia since the program went into effect.

No big surprise.

When the DA notes that, “The current way most U.S. authorities treat drug possession is shortsighted,” he ain’t kidding.

If I were a governor, this would be the first place that I would balance the budget.